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BURLINGTON, Mass. - Fractyl Health, Inc. (NASDAQ:GUTS), a clinical-stage medical technology company with a market capitalization of $95.5 million, has been granted two new U.S. patents that strengthen its intellectual property portfolio in duodenal resurfacing technology for treating metabolic diseases, according to a company press release. According to InvestingPro analysis, the company appears undervalued at its current price of $1.95, despite facing profitability challenges.
The patents, issued in May and June 2025, cover systems for ablating duodenal mucosa using thermal and non-thermal electrical energy. This technology is central to the company’s Revita device, which is designed to remodel the duodenal lining to address metabolic disorders including obesity and type 2 diabetes. While the company maintains a healthy current ratio of 2.5x, InvestingPro data shows it’s currently burning through cash with negative free cash flow of $80 million in the last twelve months.
"These new patents reinforce our leadership in gut-targeted therapies for metabolic disease," said Sarah Toomey, General Counsel and Corporate Secretary of Fractyl Health.
The company’s intellectual property portfolio now includes 31 granted U.S. patents and approximately 40 pending U.S. applications, along with numerous foreign patents and applications. Fractyl has been building this portfolio since 2011.
Revita currently has FDA Breakthrough Device designation for weight maintenance in people with obesity who discontinue GLP-1-based drugs. The device remains investigational in the United States.
Fractyl is expecting three clinical data readouts for Revita: open-label data from the REVEAL-1 Cohort in June 2025, REMAIN-1 Midpoint Cohort data in the third quarter of 2025, and 6-month primary endpoint data from the REMAIN-1 Pivotal Cohort in the second half of 2026.
The REMAIN-1 pivotal study, which is evaluating Revita in patients with obesity after discontinuation of GLP-1-based drugs, has completed enrollment.
In other recent news, Fractyl Health has reported its Q1 2025 earnings, highlighting a significant increase in research and development expenses, which rose to $19.4 million from $14.4 million in Q1 2024. This surge in R&D spending contributed to a widened net loss of $23.7 million, compared to a $3.3 million loss in the previous year. Despite the financial strain, Fractyl Health maintains a robust cash reserve of $42.1 million, ensuring operational stability into late 2025. The company is optimistic about its innovative platforms, with pivotal data releases and regulatory submissions anticipated as upcoming catalysts. Additionally, Fractyl Health has submitted the first module of its Clinical Trial Application in Europe for RJVA-001, a gene therapy candidate aimed at treating type 2 diabetes and obesity. This development is part of their broader strategy to transform metabolic disease treatment. The company also plans to initiate first-in-human dosing and report preliminary data in 2026, pending regulatory approval. These recent developments underscore Fractyl Health’s commitment to advancing its therapeutic platforms and achieving regulatory milestones.
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